These products have been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as to help prevent the spread of infection or illness during the COVID-19 pandemic. These product have not been FDA cleared or approved. This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
The mask should not be used (1) in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; (2) in a clinical setting where the infection risk level through inhalation exposure is high; or (3) in the presence of a high intensity heat source or flammable gas. Reliable Thread LLC makes no warranties, either express or implied, that the face cover prevents infection or the transmission of viruses or diseases.